Ten-year follow-up of a randomized controlled clinical trial in chronic hepatitis delta

dc.contributor.authorWranke, Anika
dc.contributor.authorHardtke, Svenja
dc.contributor.authorHeidrich, Benjamin
dc.contributor.authorDalekos, George
dc.contributor.authorYalcin, Kendal
dc.contributor.authorTabak, Fehmi
dc.contributor.authorYurdaydin, Cihan
dc.date.accessioned2020-12-01T11:58:35Z
dc.date.available2020-12-01T11:58:35Z
dc.date.issued2020
dc.departmentEge Üniversitesien_US
dc.description.abstractHepatitis delta virus (HDV) infection causes the most severe form of viral hepatitis. PEG-interferon alpha-2a (PEG-IFN alpha-2a) is the only effective treatment but its long-term clinical impact is unclear. the aim of this study was to investigate the long-term outcome after 48 weeks of pegylated interferon alpha-2a therapy. We performed a retrospective follow-up study of the Hep-Net-International-Delta-Hepatitis-Intervention-Study 1 (HIDIT-I trial). Patients had received 48 weeks of treatment with either PEG-IFN alpha-2a plus adefovir dipivoxil (ADV) (Group I), PEG-IFN alpha-2a alone (Group II) or adefovir dipivoxil alone (Group III). Liver-related complications were defined as liver-related death, liver transplantation, liver cancer and hepatic decompensation defined as development of Child-Pugh scores B or C or an increase in Model for End-stage Liver Disease (MELD) scores of five or more points in relation to baseline values. Patients were considered for further analysis when they were retreated with PEG-IFN alpha-2a. Follow-up data (at least 1 visit beyond post-treatment week 24) were available for 60 patients [Group I, (n = 19), Group II (n = 20), Group III (n = 21)]. Mean time of follow-up was 8.9 (1.6 - 13.4) years. 19 patients were retreated with IFN-based therapy: 42% (n = 8) in PEG-IFN alpha-2a arms and 58% (n = 11) in the adefovir only arm. Clinical complications on long-term follow-up occurred in 17 patients and were associated with nonresponse to therapy and baseline cirrhosis. the annual event-free survival rate in patients with cirrhosis vs noncirrhotic patients at year 5 and 10 was 70% vs 91% and 35% vs 76%. Long-term follow-up of a large randomized clinical trial suggests that off-treatment HDV RNA response to PEG-IFN alpha-2a treatment leads to improved clinical long-term outcome.en_US
dc.description.sponsorshipGerman Centre for Infection Research (DZIF), partner site Hannover-Braunschweig; German Liver Foundation; EASL registry granten_US
dc.description.sponsorshipThis study was funded by the German Centre for Infection Research (DZIF), partner site Hannover-Braunschweig with a grand to the HepNet Study-House, the German Liver Foundation and an EASL registry grant.en_US
dc.identifier.doi10.1111/jvh.13366en_US
dc.identifier.endpage1368en_US
dc.identifier.issn1352-0504
dc.identifier.issn1365-2893
dc.identifier.issue12en_US
dc.identifier.pmid32707605en_US
dc.identifier.scopus2-s2.0-85089259771en_US
dc.identifier.scopusqualityQ2en_US
dc.identifier.startpage1359en_US
dc.identifier.urihttps://doi.org/10.1111/jvh.13366
dc.identifier.urihttps://hdl.handle.net/11454/62058
dc.identifier.volume27en_US
dc.identifier.wosWOS:000558543300001en_US
dc.identifier.wosqualityQ2en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherWileyen_US
dc.relation.ispartofJournal of Viral Hepatitisen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectchronic hepatitisen_US
dc.subjectclinical outcomeen_US
dc.subjectdelta virusen_US
dc.subjectendpointen_US
dc.subjectHepatitis Den_US
dc.titleTen-year follow-up of a randomized controlled clinical trial in chronic hepatitis deltaen_US
dc.typeArticleen_US

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